During certain manufacturing processes, vessels containing various fluids are used. Often it is necessary to transfer fluid into or out of a vessel during the process and do so in a substantially aseptic manner without breaching the closed nature of the system. In particular, the need to transfer fluid often arises in the manufacturing and processing of pharmaceuticals, biopharmaceuticals, or other biotechnology applications where processes are conducted in vessels of varying shapes and sizes. The need for fluid transfer into and out of a vessel arises in other applications and industries as well, including but not limited to the production of food, cosmetics, paint, chemicals, including hazardous chemicals, and the transfer and handling of semiconductor fluids.
Regardless of the industry, during transfers or sampling, the fluid in a vessel must remain substantially free of contaminants. In addition, when making such transfers, it is desirable to keep the environment surrounding a vessel free from contamination by the contents of the vessel or a sample taken therefrom. It is often the case that, throughout the manufacturing process, there is a need to maintain fluid communication with the interior of the vessel by way of, for example, tubing extending through a vessel closure from the exterior of the vessel into the interior of the vessel. To accomplish a substantially aseptic transfer, it is desirable to control the environment through which the fluid flows, for example, the pathway from a vessel to a sample container should be substantially aseptic along the entire pathway. Furthermore, it is desirable that the vessel closure be safe for use, reliable, and of low-cost construction.
It is also desirable to transfer fluid using a vessel closure which is pre-sterilized and disposable. A pre-sterilized, disposable vessel closure avoids the need for an operator to sterilize the vessel closure for use. Further, such sterilization can damage vessel closures and render them useless before their first use.
Known vessel closures utilize either thermoplastic or elastomeric tubing to create fluid communication with the interior of a vessel. Known vessel closures use, for example, all elastomeric tubing, such as silicone tubing, or utilize all thermoplastic tubing, such as C-Flex® tubing. Vessel closures incorporating elastomeric tubing are often manufactured using insert injection molding at temperatures between 350° to 400° F. These temperatures will melt or damage thermoplastic tubing. Further, vessel closures manufactured with silicone seals have not heretofore included thermoplastic tubing due to the lack of adhesion of silicone directly onto thermoplastic tubing.
Thus, what is needed is a vessel closure with a seal capable of adhering to silicone tubing or other inserts. What is also needed is a vessel closure with a seal with both elastomeric and thermoplastic tubing within the same vessel closure wherein the tubing creates a substantially aseptic fluid pathway into and out of a vessel. What is further needed are manufacturing techniques for manufacturing a low cost, disposable vessel closure with both elastomeric and thermoplastic tubing wherein the tubing creates a substantially aseptic fluid pathway into and out of a vessel. What is also needed is a method of using the aforementioned vessel closures to circulate fluid into and out of a vessel while also having the option of controlling the temperature of the fluid.